Woodsmoke Exposure, Influenza Infection, and Nasal Immunity
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: LAIV nasal vaccine is chosen as a model viral infection, Wood smoke, Placebo for LAIV nasal vaccine is chosen as a model viral infection, Placebo for Wood Smoke (clean Air Exposure).
- Кому может быть актуально
- Состояния в реестре: Smoke Exposure, Influenza. Базовые параметры: 18 лет — 49 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effects of Woodsmoke Exposure on Nasal Immune Responses to Influenza Infection in Normal Human Volunteers
Обзор
This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases in Live Attenuated Influenza Virus (LAIV) -induced nasal symptoms, and reduces mucosal antibody production.
Подробное описание
This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases LAIV-induced nasal symptoms, and reduces mucosal antibody production. Healthy volunteers will be randomized for a 2-hr exposure to WS or placebo (filtered air) and then inoculated with either live attenuated influenza virus (LAIV) or placebo. Nasal mucosal samples, symptoms, and peripheral blood will be collected on days 1,2,3,7, and 21 post-exposure/LAIV and assessed for a) mucosal antiviral responses using targeted and non-targeted analysis of the secretome and tissue-level gene expression; b) symptoms, virus quantity, differential cell count, and virus-specific antibody levels; and c) biomarker signatures associated with infection outcomes using computational modeling tools.
Вмешательства
- Биопрепарат LAIV nasal vaccine is chosen as a model viral infection
Inoculation with LAIV - Другое Wood smoke
Wood smoke exposure concentrations at 500 ug/m3 for two hours. - Биопрепарат Placebo for LAIV nasal vaccine is chosen as a model viral infection
Placebo for LAIV inoculation. Nasal administration of normal saline. - Другое Placebo for Wood Smoke (clean Air Exposure)
Clean Air Exposure for 2 hours
Первичные конечные точки
- Nasal Mucosal secretome (AUC) [Срок оценки: Day 0 to Day 7]
- Gene Expression (AUC) [Срок оценки: Day 0 to Day 7]
- Virus Quantity (AUC) [Срок оценки: Day 0 to Day 7]
- Nasal Neutrophils (AUC) [Срок оценки: Day 0 to Day 7]
- Nasal Viral Antibodies (AUC) [Срок оценки: Day 0 to Day 7]
- Blood Viral Antibodies (AUC) [Срок оценки: Day 0 to Day 7]
Вторичные конечные точки (12)
- Peak Tissue gene expression [Срок оценки: Day 0 to Day 21]
- Peak nasal secretome [Срок оценки: Day 0 to Day 21]
- Peak Nasal Virus quantity [Срок оценки: Day 0 to day 21]
- Peak nasal neutrophils [Срок оценки: Day 0 to Day 21]
- Peak Nasal virus anti-bodies [Срок оценки: Day 0 to Day 21]
- Peak blood virus anti-bodies [Срок оценки: Day 0 to Day 21]
- Peak Day of Tissue Gene Expression [Срок оценки: Day 0 to Day 21]
- Peak Day of nasal secretome [Срок оценки: Day 0 to Day 21]
- Peak Day of Nasal Virus quantity [Срок оценки: Day 0 to day 21]
- Peak Day of nasal neutrophils [Срок оценки: Day 0 to Day 21]
- Peak Day of Nasal virus anti-bodies [Срок оценки: Day 0 to Day 21]
- Peak Day of blood virus anti-bodies [Срок оценки: Day 0 to Day 21]
Критерии участия
Критерии включения
- Normal lung function,
- oxygen saturation of >94%,
- normal blood pressure,
- no respiratory symptoms on history, no abnormalities on exam, normal pulmonary function testing,
- 18-49 Years of age.
Критерии исключения
- A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)
- Positive pregnancy test within 48 hours of the time of challenge
- Use of any inhaled substance (for medical or recreational purposes).
- Nonsmokers must have been abstinent from smoking for the prior 12 months, having not smoked more than 1 pack over the course of the previous year.
- History of allergy to eggs
- Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks
- Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion.
- Expected exposure of subject to immunocompromised individuals (who can be infected by LAIV) for the 3 weeks following LAIV inoculation.
- Use of immunosuppressive drugs within the past 6 months.
- Previous Woodsmoke exposure <3 weeks, which is considered to an appropriate washout period
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- Mary Ellen Jones — Chapel Hill
Идентификаторы
NCT: NCT06841913 · 24-1802 · 1R01ES036209-01